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CoreValve and Evolut transcatheter valves

A family of replacement aortic valves from Medtronic that are put in through a catheter, a procedure called TAVR. The US FDA approved the CoreValve in 2014 for people who could not have open-heart surgery or were at extreme risk, and in 2019 widened the approval for the Evolut R and Evolut PRO valves to people at low surgical risk. The Evolut Low Risk trial tested the family against surgery.

Also called Medtronic CoreValve · Evolut R · Evolut PRO · Evolut

  • Product
  • In this atlas

Overview

Technical summary

Medtronic CoreValve System (PMA P130021 original approval, 2014-01-17, extreme risk or inoperable) and the Medtronic CoreValve Evolut R and Evolut PRO systems (supplement S058, 2019-08-16, adds low surgical risk), FDA product code NPT. The Evolut Low Risk abstract describes a self-expanding supraannular bioprosthesis; its registry record names the Medtronic CoreValve System and the Medtronic CoreValve Evolut R System. Later systems under the same PMA number are not read here.

Product details

Type
Device
Model or formulation
Medtronic CoreValve System; CoreValve Evolut R and Evolut PRO systems
Version
The original approval names the CoreValve System. The 2019 supplement names the Evolut R and Evolut PRO systems. Later systems under the same PMA number are not read here.

Intended-use sources

  1. Background FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
    Reuse basis
    openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

  2. Background FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-10-05
    Source state
    Current
    Snapshot hash
    27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
    Reuse basis
    openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

Claims and evidence

Context Patients with severe aortic stenosis at low surgical risk, randomized in the Evolut Low Risk trial

Recipient
Recipient not specified
Population
Patients with severe aortic stenosis and low surgical risk, 1468 of whom were randomized. The abstract gives a mean age of 74 years. The registry lists no minimum or maximum age. The registry record also covers a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
Care setting
Not stated in the abstract. The registry lists sites in the United States, Australia, Canada, France, Japan, the Netherlands and New Zealand.
Geography
United States, Australia, Canada, France, Japan, the Netherlands and New Zealand (registry locations)
Life stage
Mean age 74 years (abstract); the registry lists no age limits
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
The primary end point was at 24 months, analyzed when 850 patients had reached 12-month follow-up (abstract). 30-day outcomes and 12-month valve measurements are also reported. The registry gives an estimated study completion of 2029-06.
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • Severe aortic stenosis
  • Low surgical risk
Excluded
None stated

  • Safety Interventional Certainty not assessed

    At 30 days in the Evolut Low Risk trial, patients who had TAVR, compared with surgery, had less disabling stroke (0.5% versus 1.7%), fewer bleeding complications (2.4% versus 7.5%), less acute kidney injury (0.9% versus 2.8%) and less atrial fibrillation (7.7% versus 35.4%). They also had more moderate or severe aortic regurgitation (blood leaking back through the aortic valve, 3.5% versus 0.5%) and more pacemaker implantation (17.4% versus 6.1%). At 12 months the valve gradient was lower with TAVR (8.6 versus 11.2 mm Hg) and the effective orifice area larger (2.3 versus 2.0 cm2).

    Applies to Recipient not specified
    • Patients with severe aortic stenosis and low surgical risk, 1468 of whom were randomized. The abstract gives a mean age of 74 years. The registry lists no minimum or maximum age. The registry record also covers a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
    • Not stated in the abstract. The registry lists sites in the United States, Australia, Canada, France, Japan, the Netherlands and New Zealand.
    • United States, Australia, Canada, France, Japan, the Netherlands and New Zealand (registry locations)
    • Mean age 74 years (abstract); the registry lists no age limits
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up The primary end point was at 24 months, analyzed when 850 patients had reached 12-month follow-up (abstract). 30-day outcomes and 12-month valve measurements are also reported. The registry gives an estimated study completion of 2029-06.
    Certainty method
    Not assessed
    Limitations
    The abstract gives these percentages without counts, intervals or tests, so no statement of significance is made here. The harms of TAVR (aortic regurgitation and pacemakers) are as important to this claim as the benefits. Funded by Medtronic. The registry lists no masking. Only the abstract was read. The 24-month result is in a separate claim.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (2)

    1. Supports Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1816885 · PMID: 30883053

      Locator
      Abstract, RESULTS, sentence 4
      How it applies
      30-day outcomes in both directions.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    2. Supports Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1816885 · PMID: 30883053

      Locator
      Abstract, RESULTS, sentence 5
      How it applies
      12-month valve gradient and orifice area.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  • Effect Interventional Certainty not assessed

    In the Evolut Low Risk trial, 1468 patients with severe aortic stenosis and low surgical risk were randomized to TAVR with a self-expanding valve or to surgery. At 24 months the estimated rate of death or disabling stroke was 5.3% with TAVR and 6.7% with surgery (a difference of -1.4 percentage points; 95% Bayesian credible interval for the difference -4.9 to 2.1; posterior probability of noninferiority above 0.999). The authors conclude TAVR was noninferior to surgery. The abstract reports a noninferiority result only and no test of superiority.

    Applies to Recipient not specified
    • Patients with severe aortic stenosis and low surgical risk, 1468 of whom were randomized. The abstract gives a mean age of 74 years. The registry lists no minimum or maximum age. The registry record also covers a continued access study. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
    • Not stated in the abstract. The registry lists sites in the United States, Australia, Canada, France, Japan, the Netherlands and New Zealand.
    • United States, Australia, Canada, France, Japan, the Netherlands and New Zealand (registry locations)
    • Mean age 74 years (abstract); the registry lists no age limits
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up The primary end point was at 24 months, analyzed when 850 patients had reached 12-month follow-up (abstract). 30-day outcomes and 12-month valve measurements are also reported. The registry gives an estimated study completion of 2029-06.
    Certainty method
    Not assessed
    Limitations
    Funded by Medtronic; the registry lists Medtronic Cardiovascular as lead sponsor and FDA lists Medtronic, Inc. as applicant for the valve. The registry lists no masking. The result is a noninferiority result from a Bayesian analysis done when 850 patients had reached 12-month follow-up; it is not a statement that TAVR lowers events. Results are for one self-expanding valve in selected low-risk patients and do not extend to other valves or to higher-risk patients. Only the abstract was read: the NEJM page was not fetched for this paper, and PubMed lists no open full text. The 30-day harms are in a separate claim and should be read with this one.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (5)

    1. Supports Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1816885 · PMID: 30883053

      Locator
      Abstract, RESULTS, sentence 3
      How it applies
      24-month rates of the primary end point, the difference, the credible interval and the probability of noninferiority.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    2. Supports Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1816885 · PMID: 30883053

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      The authors conclude noninferiority.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    3. Background Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1816885 · PMID: 30883053

      Locator
      Abstract, METHODS, sentences 1 and 2
      How it applies
      Design, population and the Bayesian analysis of the 24-month end point.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    4. Background Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2019-05-02 · DOI: 10.1056/NEJMoa1816885 · PMID: 30883053

      Locator
      Abstract, RESULTS, sentences 1 and 2
      How it applies
      Number randomized and mean age.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      2445020790db2a4118e68c6f0cf93ae50a1b0d3b0959caefe52e7905518737f4
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

    5. Background Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2026-05-07. · NCT: NCT02701283

      Locator
      protocolSection.designModule.designInfo.maskingInfo.masking
      How it applies
      The registry records no masking.
      Retrieved
      Source effective date
      2026-05-07
      Source state
      Current
      Snapshot hash
      bd30fbe5fbcc66a1a6b6a87329c13591d0f40b947c57fbbe55d5aa866879c467
      Reuse basis
      Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT02701283.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

Context United States PMA approval P130021: CoreValve for severe aortic stenosis at extreme risk or inoperable

Recipient
Recipient not specified
Population
People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, with a native aortic annulus 18 to 29 mm across, whom a heart team that includes a cardiac surgeon judges to be at extreme risk with open surgery or unable to have it. The order gives no age range.
Care setting
Not stated in the FDA record beyond the heart team judgement
Geography
United States (decision by the US Food and Drug Administration)
Life stage
Not stated in the FDA record
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: 3 inclusion criteria; exclusion criteria not stated
Included
  • Heart disease with symptoms caused by severe calcific narrowing of the person's own (native) aortic valve
  • Native aortic annulus 18 to 29 mm across
  • A heart team that includes a cardiac surgeon judges the person to be at extreme risk with open surgery or unable to have it
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2014-01-17 the US Food and Drug Administration approved the Medtronic CoreValve System under PMA P130021, product code NPT, applicant Medtronic, Inc. According to the approval order, the system is for easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whose native aortic annulus measures 18 to 29 mm across, and whom a heart team that includes a cardiac surgeon judges to be at extreme risk with open surgery or unable to have it. The summary of safety and effectiveness defines severe stenosis as an aortic valve area of 0.8 cm2 or less, or a mean aortic valve gradient above 40 mmHg, or a peak velocity of the aortic jet above 4.0 m/s, and it describes extreme risk as a predicted risk of operative death, of serious irreversible morbidity, or of both, of 50% or more at 30 days. openFDA prints a question mark in place of those two comparison symbols, so the readings come from the summary.

    Applies to Recipient not specified
    • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, with a native aortic annulus 18 to 29 mm across, whom a heart team that includes a cardiac surgeon judges to be at extreme risk with open surgery or unable to have it. The order gives no age range.
    • Not stated in the FDA record beyond the heart team judgement
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. This original approval covers extreme risk or inoperable patients only. The low-risk supplement S058 has its own record.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (9)

    1. Supports FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      results[0].pma_number
      How it applies
      The PMA number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    2. Supports FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    3. Supports FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      results[0].trade_name
      How it applies
      The trade name FDA gives this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    4. Supports FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      results[0].decision_date
      How it applies
      ISO date of the decision.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    5. Supports FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      results[0].decision_code
      How it applies
      FDA decision code: APPR is an approval.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    6. Supports FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      results[0].product_code
      How it applies
      FDA product code of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    7. Supports FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      results[0].ao_statement
      How it applies
      FDA approval order statement: the approved indication, quoted in fragments.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    8. Background FDA premarket approval record P130021: Medtronic CoreValve System (original PMA approval) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 (the earliest record by decision date, which is the original approval, with no supplement number), from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record. · PMA: P130021

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      57604c3fcc7cf2b97646a6e9356ea8a963da82bdae5000459beb4044bd482a86
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    9. Supports FDA summary of safety and effectiveness data for PMA P130021 (CoreValve)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database.

      Locator
      Section II, Indications for use
      How it applies
      The summary of safety and effectiveness prints the area and risk thresholds with their comparison symbols, which openFDA drops.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      27c089e297885755028555129a7bc344e56278992a585790769c22fb7f8b9d66
      Reuse basis
      FDA document fetched 2026-10-14 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed.

Context United States PMA supplement P130021 S058: Evolut R and Evolut PRO for severe aortic stenosis at low surgical risk

Recipient
Recipient not specified
Population
People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement, including people for whom the risk of surgical aortic valve replacement is low. The order gives no age range.
Care setting
Not stated in the FDA record beyond the heart team judgement
Geography
United States (decision by the US Food and Drug Administration)
Life stage
Not stated in the FDA record
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: 2 inclusion criteria; exclusion criteria not stated
Included
  • Heart disease with symptoms caused by severe calcific narrowing of the person's own (native) aortic valve
  • A heart team that includes a cardiac surgeon judges transcatheter heart valve replacement suitable for the person
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 2019-08-16 the US Food and Drug Administration approved PMA supplement S058 to P130021, applicant Medtronic, Inc. It covers the Medtronic CoreValve Evolut R System together with the Medtronic CoreValve Evolut PRO System. The supplement widens the use of these systems to people for whom the risk of surgical aortic valve replacement is low. The use it describes is easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement.

    Applies to Recipient not specified
    • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement, including people for whom the risk of surgical aortic valve replacement is low. The order gives no age range.
    • Not stated in the FDA record beyond the heart team judgement
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA record
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. The openFDA record does not name the trial behind the supplement, so this record does not link the supplement to the Evolut Low Risk trial.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (10)

    1. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].pma_number
      How it applies
      The PMA number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    2. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].supplement_number
      How it applies
      The supplement number of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    3. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].applicant
      How it applies
      The applicant, as FDA writes the name.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    4. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].trade_name
      How it applies
      The trade name FDA gives this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    5. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].decision_date
      How it applies
      ISO date of the decision.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    6. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].decision_code
      How it applies
      FDA decision code: APPR is an approval.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    7. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].product_code
      How it applies
      FDA product code of this record.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    8. Supports FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      results[0].ao_statement
      How it applies
      FDA approval order statement: the approved indication, quoted in fragments.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    9. Background FDA premarket approval record P130021/S058: Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058, low-risk indication) (openFDA record)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA PMA record returned on 2026-10-14 for P130021 supplement S058, from a dataset last updated 2026-10-05. The FDA PMA database page was not fetched for this record.

      Locator
      meta.disclaimer
      How it applies
      openFDA's own disclaimer about relying on its data.
      Retrieved
      Source effective date
      2026-10-05
      Source state
      Current
      Snapshot hash
      27578cf75c2e7418edaa553aff242af8b6d3800dd4db1c7b28d6ec5c35976948
      Reuse basis
      openFDA data is public domain and made available under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as cj-openfda-license.html, hash only). The raw record is committed at research/snapshots/cj-openfda-pma-P130021-S058.json. The record gives the applicant's street address; records here do not repeat it. This record's own openFDA block (device name, class, registration numbers) is not used beyond the device class.

    10. Supports FDA approval order for PMA supplement P130021/S058 (CoreValve Evolut R and Evolut PRO, low-risk indication)

      Regulator · U.S. Food and Drug Administration · Edition PDF fetched 2026-10-14; text read with pdftotext. The decision document of the FDA PMA database. · PMA: P130021/S058

      Locator
      page 1, Re: line
      How it applies
      The FDA approval order names the supplement as P130021/S058.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e0f375986b580ef4181c8cc7e828c37f74da0a9abdf93f83a762b93c5b677cb7
      Reuse basis
      FDA document fetched 2026-10-14 from accessdata.fda.gov. FDA's own website reuse terms were not read for this atlas, so public text is cite_only until they are. Hash only; the PDF is not committed.

Authorization

Regulatory decision: CoreValve and Evolut transcatheter valves

Applies to Recipient not specified
  • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement, including people for whom the risk of surgical aortic valve replacement is low. The order gives no age range.
  • Not stated in the FDA record beyond the heart team judgement
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA record
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Supplemental approval,
Pathway
PMA
Submission
P130021/S058
Product code
NPT
Device class
Class III
Jurisdictions
United States; note: United States
Product version
Medtronic CoreValve Evolut R and Evolut PRO systems (PMA supplement S058)
Indication
PMA supplement S058 expands the indication to include patients at low risk for surgical aortic valve replacement, for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis whom a heart team, including a cardiac surgeon, judges appropriate for transcatheter heart valve replacement therapy.
Basis
On 2019-08-16 the US Food and Drug Administration approved PMA supplement S058 to P130021, applicant Medtronic, Inc. It covers the Medtronic CoreValve Evolut R System together with the Medtronic CoreValve Evolut PRO System. The supplement widens the use of these systems to people for whom the risk of surgical aortic valve replacement is low. The use it describes is easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whom a heart team that includes a cardiac surgeon judges suitable for transcatheter heart valve replacement.

Limitations. openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. The openFDA record does not name the trial behind the supplement, so this record does not link the supplement to the Evolut Low Risk trial.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Regulatory decision: CoreValve and Evolut transcatheter valves

Applies to Recipient not specified
  • People with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, with a native aortic annulus 18 to 29 mm across, whom a heart team that includes a cardiac surgeon judges to be at extreme risk with open surgery or unable to have it. The order gives no age range.
  • Not stated in the FDA record beyond the heart team judgement
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA record
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
PMA
Submission
P130021
Product code
NPT
Device class
Class III
Jurisdictions
United States; note: United States
Product version
Medtronic CoreValve System (original approval)
Indication
Relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis, with native aortic annulus diameters between 18 and 29 mm, whom a heart team, including a cardiac surgeon, judges to be at extreme risk or inoperable for open surgical therapy.
Basis
On 2014-01-17 the US Food and Drug Administration approved the Medtronic CoreValve System under PMA P130021, product code NPT, applicant Medtronic, Inc. According to the approval order, the system is for easing aortic stenosis in people with heart disease with symptoms caused by severe calcific narrowing of their own (native) aortic valve, whose native aortic annulus measures 18 to 29 mm across, and whom a heart team that includes a cardiac surgeon judges to be at extreme risk with open surgery or unable to have it. The summary of safety and effectiveness defines severe stenosis as an aortic valve area of 0.8 cm2 or less, or a mean aortic valve gradient above 40 mmHg, or a peak velocity of the aortic jet above 4.0 m/s, and it describes extreme risk as a predicted risk of operative death, of serious irreversible morbidity, or of both, of 50% or more at 30 days. openFDA prints a question mark in place of those two comparison symbols, so the readings come from the summary.

Limitations. openFDA copies the approval order statement and may lose characters; where a symbol is missing it is not restored here. The FDA PMA database page, the approval order and the summary of safety and effectiveness were not read, so conditions of approval and trial results are not recorded. An approval is a regulatory decision and not a finding about how well the device works for any person. openFDA's own disclaimer says not to rely on it to make decisions regarding medical care. This original approval covers extreme risk or inoperable patients only. The low-risk supplement S058 has its own record.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:corevalve-evolut
Content hash
c971d6622ca8ec79386df9f1dcaae6fbe7e52945af7feb88496d7c01e75a8f90